Label: GUAIFENESIN EXTENDED RELEASE 600 MG- guaifenesin tablet, extended release

  • NDC Code(s): 62011-0382-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 6, 2022

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  • ACTIVE INGREDIENT(in each extended-release tablet)

    Guaifenesin 600 mg

  • PURPOSE

    Expectorant

  • USE(S)

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • WARNING

    .

  • DO NOT USE

    for children under 12 years of age

  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)
  • STOP USE AND A ASK DOCTOR IF

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
  • IF PREGNANT OR BREAST-FEEDING,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • DIRECTIONS

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 to 2 tablets every 12 hours.  
    • Do not exceed 4 tablets in 24 hours.
    • children under 12 years of age: do not use
  • OTHER INFORMATION

    • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
    • store between 20 to 25°C (68 to 77°F)
  • INACTIVE INGREDIENTS

    carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

  • QUESTIONS?

    1-609-860-2600

    Hours: 8am - 4pm, EST

    You may also report side effects to this phone number. 

  • PRINCIPAL DISPLAY PANEL

    NDC 62011-0382-1

    HealthMart
    Compare to Mucinex Extended Release 600mg Tablets Active Ingredient*

    12 HOUR

    Mucus Relief

    Guaifenesin Extended-Release Tablets 600 mg

    Expectorant

    Relieves Chest Congestion

    Thins and Loosens Mucus

    40 EXTENDED-RELEASE TABLETS


    42

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN EXTENDED RELEASE 600 MG 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0382
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code G233
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0382-14 in 1 CARTON10/17/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20921510/17/2019
    Labeler - Strategic Sourcing Services LLC (116956644)
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